March 1, 2023
National Center for Advancing Translational Sciences (NCATS)
The mission of the National Center for Advancing Translational Sciences (NCATS) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and dissemination of effective medical/behavioral interventions diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS Clinical and Translational Science Awards (CTSA) Program supports a consortium of CTSAs located at medical research institutions across the Nation (see https://ncats.nih.gov/ctsa/about). The focus of this consortium is to foster high-quality, collaborative translational science, essential to meeting the NCATS mission. This is performed through innovation in translational science, workforce development, infrastructure support, trans-consortium collaboration, and community engagement.
An evolving trend in clinical trial (https://grants.nih.gov/policy/clinical-trials/definition.htm) design has been for their decentralization or their ability to be performed in part, or entirely away from traditional medical research institutions. Decentralized clinical trials (DCTs) have the potential to improve the efficiency and speed of implementation for interventions, treatments, and/or diagnostics to be brought to individuals and populations. Decentralized or hybrid clinical trials are the common terms for these types of trial designs. To enable their proportionately or entirely offsite designs, they utilize community providers and technology to implement, deliver data (e.g., regarding safety, efficacy), or relay feedback about participant status. Indeed, this is performed through a combination of software, digital health technologies (including in-home objective measures, wearables, etc.), telemedicine, community healthcare providers, local pharmacies, mobile research units, point-of-care diagnostics, and more. They offer opportunities to: decrease burden(s) to trial participants (e.g., distance, monetary, logistical, emotional); improve recruitment and retention enabling medical/health interventions to succeed or fail faster without early termination; and deliver more real world, generalizable clinical research findings from broader participation. However, challenges do exist to accelerating this clinical research approach.
Overcoming these challenges is in line with the mission of NCATS as well as the CTSA Program. To advance the ability to perform decentralized or hybrid trials, much is needed, including: gaining a deeper understanding of the interplay of the clinical and translational processes inherent to offsite clinical trials such as clinical workflow integration and patient reporting; robust community engagement and human-centered design; bespoke resources that could be leveraged to rapidly implement and operationalize; collaborations and partnerships developed; continued development, validation and implementation of the enabling tools such as informatics systems, data integration platforms, digital health technologies (e.g., those that use computing platforms, connectivity, software or sensors for remote data collection) including machine learning or artificial intelligence to integrate disparate data types and linking outcomes, and ensuring that data from DCTs can be used by regulatory bodies and will be adopted by clinicians.
This RFI invites stakeholders throughout the scientific research, advocacy, clinical practice, industry, patient and lay communities, including the general public, to comment on how DCTs may be designed to be more effective, efficient and equitable to bring more interventions to all people, faster. In particular, comments are sought on ways to enable participants from 1) diverse backgrounds, that includes, but is not limited to race, ethnicity, socioeconomic status, background, gender, and mental or physical ability; and 2) those who are underserved, used in the context of Health Disparities related to population-based health. A population is defined by the Minority Health and Health Disparities Research and Education Act of 2000 (Public Law 106-525) as a health disparity or underserved population if there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population, to participate in clinical trials. These comments can be with respect to the CTSAs and/or the broader academic medical research enterprise.
Possible areas for comment include, but are not limited to:
Application of research methods in decentralized clinical trials (DCTs)
Resources, Infrastructure, and Enabling Technologies
Partnerships and/or Collaborations
Study Participation and Adherence
Data integration, quality, accessibility, and reproducibility
Privacy and Regulatory Considerations
The above scientific areas and issues of interest are examples. Respondents are welcome to note and provide comments on other areas and issues they deem important or essential to consider.
How to submit
Responses to this RFI must be submitted electronically to the following NIH RFI submission link (https://rfi.grants.nih.gov/?s=63d1730a815c8d599f0af604). Responses must be received by 11:59 p.m. (Eastern Standard Time) on May 12, 2023. Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. If information you provide is available on a website or in published material, please provide appropriate links. No forms are required for submission. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.
This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Governments use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Governments use of such information.
NIH looks forward to your input and we hope that you will share this RFI document with your colleagues.
Christopher M Hartshorn, Ph.D.
National Center for Advancing Translational Sciences
Erica Rosemond, Ph.D.
National Center for Advancing Translational Sciences